A Pragmatic Clinical Trial of the WE BEAT Well-Being Education Program in Adolescent Congenital Heart Disease: WE BEAT CHD Study
PHN WBC
2 other identifiers
interventional
390
1 country
14
Brief Summary
The goal of this pragmatic clinical trial is to learn if the WE BEAT program, a 5-week group-based online wellbeing and skill-building program, can help teens with congenital heart disease (CHD) improve their ability to handle stress. The main question it aims to answer is if participants who receive the WE BEAT program become more resilient (the ability to bounce back from from tough times or recover from something difficult) and have better quality of life compared to participants who receive usual care. The study also aims to learn if there are connections between participant-reported psychosocial data (such as resilience, feelings about one's life and one's physical, mental, and social wellbeing) and clinical outcomes. Eligible participants who are 12-17-year-old will be in the study for about 6 months and be randomized to receive either the WE BEAT program or usual care. Following completion of the primary WE BEAT intervention at Week 5, intervention arm participants will be randomized to a single-session booster session (occurring at Week 18) vs no booster session. The booster session will be provided in a similar format to the WE BEAT program. A review of all modules/skills introduced in the program will be provided. All participants will complete 4 sets of online surveys and give 3 hair/saliva samples at different timepoints. Some participants may volunteer to give optional blood and urine samples.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2026
Longer than P75 for not_applicable
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 23, 2026
CompletedStudy Start
First participant enrolled
April 1, 2026
CompletedFirst Posted
Study publicly available on registry
April 13, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2029
April 23, 2026
April 1, 2026
3 years
March 23, 2026
April 21, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Connor-Davidson Resilience Scale (CD-RISC)
Connor-Davidson Resilience Scale© (CD-RISC©) is a self-reported, unidimensional 5-point Likert scale measuring resilience. Total scores range from 0-40 with higher scores indicating greater resilience. It has been validated for use in children and adolescents across various countries.
from baseline to week 5 (immediately post-intervention).
Secondary Outcomes (14)
Connor-Davidson Resilience Scale (CD-RISC)
from baseline to Week 18, from baseline to week 30, from baseline to week 5 (for the subpopulation of participants with moderate to low baseline CD-RISC)
NIH Patient-Reported Outcomes Measurement Information System (PROMIS) Scales
from baseline to week 5, baseline to week 18, baseline to week 30
Kessler-6 (K6)
from baseline to week 5, baseline to week 18, baseline to week 30
PedsQL, Generic Core and Cardiac Module
from baseline to week 5, baseline to week 18, baseline to week 30
Life's Essential 8
from baseline to week 5, baseline to week 18, baseline to week 30
- +9 more secondary outcomes
Study Arms (2)
Usual Care
NO INTERVENTIONUsual Care arm used as a control
Intervention arm
EXPERIMENTALWE BEAT telemedicine intervention
Interventions
Improving Access and Increasing Resilience through the WE BEAT Well-Being Education Program. The WE BEAT Well-Being Education Program was developed for pediatric patients with heart disease. The evidence-based components of the 5-module WE BEAT intervention are derived from cognitive behavioral theory, stress management and resiliency research, and behavioral intervention science across pediatric populations and adult heart disease. The five WE BEAT modules include: Well-being Education--Introduction, Breathe--Mindfulness and Relaxation-Based Skills, Energize--Positive Psychology Skills, Adjust--Cognitive Skills Training, and Thanks--Gratitude Practice. The objective is to foster positive psychological well-being and resilient outcomes in adolescents with CHD through a mental health promotion and prevention while providing access to safe, peer-to-peer community building. Through its group-based telemedicine delivery, the program aims to increase access to mental health care.
Eligibility Criteria
You may qualify if:
- Age 12-17 years old
- CHD of moderate or severe complexity (Class II/III, 2018 AHA/ACC ACHD, Table 4)
- English or Spanish language proficiency
- Receives cardiology care at a PHN or PHN auxiliary site
- Parent or guardian and participant willing to comply with protocol and provide written/electronic informed consent and assent
You may not qualify if:
- CHD of mild or simple complexity (Class I, 2018 AHA/ACC ACHD, Table 4)
- Prior heart transplant to treat CHD
- Heart disease that is not classified as structural CHD (e.g., connective tissue disease, genetic cardiomyopathy, or acquired heart disease)
- Cognitive or developmental conditions that limit program participation and/or ability to complete self-reported measures as determined by a primary cardiology clinician
- Suicidality, homicidality, or psychosis in the past 12 months as per medical chart review, clinician report, or eligibility screening
- Medically unable to participate (e.g., intubated, unable to respond verbally, active delirium)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (14)
Stanford School of Medicine
Stanford, California, 94305, United States
Children's Hospital Colorado
Aurora, Colorado, 80045, United States
Emory University School of Medicine
Atlanta, Georgia, 30322, United States
University of Kentucky College of Medicine
Lexington, Kentucky, 40506, United States
Boston Children's Hospital
Boston, Massachusetts, 02114, United States
University of Michigan Health System
Ann Arbor, Michigan, 48109, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Icahn School of Medicine at Mount Sinai
New York, New York, 10029, United States
Columbia University Irving Medical Center
New York, New York, 10032, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15224, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Primary Children's Hospital, University of Utah
Salt Lake City, Utah, 84108, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Melissa Cousino, PhD
University of Michigan
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 23, 2026
First Posted
April 13, 2026
Study Start
April 1, 2026
Primary Completion (Estimated)
April 1, 2029
Study Completion (Estimated)
June 1, 2029
Last Updated
April 23, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- Public Use Datasets will be created and posted within the time-limits required by NHLBI
- Access Criteria
- Will be posted on the Web and available to general public
PUD (Public Use Datasets) are planned to be created at the end of the study